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Clinical Trials/NCT06482450
NCT06482450
Recruiting
Not Applicable

Improving Vaccine Acceptance Through EHR Integrated Patient- and Provider-Facing Decision Support

Johns Hopkins Bloomberg School of Public Health1 site in 1 country1,200 target enrollmentJune 11, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vaccine Hesitancy
Sponsor
Johns Hopkins Bloomberg School of Public Health
Enrollment
1200
Locations
1
Primary Endpoint
Vaccination rate
Status
Recruiting
Last Updated
9 months ago

Overview

Brief Summary

The goal of this project is to establish the technical feasibility of a scalable, integrated platform to improve patient informed decision-making and increase vaccine uptake and to evaluate the effectiveness of the integrated platform to improve vaccine uptake.

Detailed Description

The first study objective is to establish the technical feasibility of a scalable, integrated platform to improve patient informed decision-making and increase vaccine uptake. The investigators have established a partnership between vaccine safety and hesitancy experts at the Institute for Vaccine Safety at Johns Hopkins and clinical informatics and implementation experts at Emory University and Children's Healthcare of Atlanta (CHOA). This team will design a technology architecture to accomplish the following goals: (1) provide patients/parents with tailored vaccine messaging videos through the LetsTalkShots (LTS) platform; (2) leverage the same LTS logic that determines which videos are shown in LTS and push associated talking points into the EHR; (3) display patient-specific talking points at the right time in clinical workflows to promote an evidence-based vaccine conversation; (4) centralize maintenance of this messaging with the LTS application; (5) minimize resources required from each healthcare institution to go live with the integrated platform; and (6) establish revenue-generating mechanisms for LTS (e.g. licensing fees) and each healthcare institution (e.g. billing for vaccine counseling). The second study objective is to evaluate the effectiveness of the integrated platform to improve vaccine uptake. First, providers at the CHOA Hughes Spalding Primary Care clinic will have two opportunities to participate in a 1 hour Continuing Medical Education (CME) session on evidence-based vaccine communication. For intervention visits, parents of undervaccinated patients with upcoming appointments will receive a text message appointment reminder with a link to an EHR-integrated questionnaire on vaccine intent and concerns. This questionnaire will drive the patient/parent to view tailored LTS videos, while pushing the associated talking points back to the clinician at the time of the appointment. For control visits, parents will receive appointment reminders per usual care. Primary outcome: Administration of recommended vaccines at the index appointment. Mixed effects multivariable logistic regression will evaluate the influence of the integrated platform on the primary outcome, adjusted for demographics. The study hypothesis is that among visits with integrated decision support, vaccination rates will be 10% higher (absolute) than control visits with no such decision support.

Registry
clinicaltrials.gov
Start Date
June 11, 2025
End Date
June 1, 2026
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Patient has an upcoming appointment in 2 business days at Children's Healthcare of Atlanta Hughes Spalding Primary Care Clinic.
  • A valid mobile phone number or e-mail address is available in the EHR as of 2 business days prior to the appointment date.
  • Phase 1: COVID-19 Vaccine only:
  • Due for a COVID-19 vaccine based on Epic Systems© COVID-19 vaccine health maintenance topic.
  • Phase 2: All Vaccines:
  • Due for any vaccines based on Epic Systems© implementation using health maintenance topics of the Centers for Disease Control CDS for Immunization (CDSi) specifications.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Vaccination rate

Time Frame: Baseline

Proportion of vaccines due that are administered at the index appointment

Secondary Outcomes

  • Days undervaccinated(Through 24 months of age)
  • Patient Adoption as assessed by proportion of successful texts sent(Up to one year)
  • Provider Adoption as assessed by proportion of orders opened(Up to one year)

Study Sites (1)

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